BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG

    MDR report key: 11257680 · Received February 1, 2021

    Report

    Report Number
    9610824-2021-00002
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    January 4, 2021
    Report Date
    March 4, 2021
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHS
    UDI-DI
    07611969952168
    PMA / PMN Number
    125529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED QUESTIONABLE RESULTS IN MANUAL TESTING USING THE IH-READER 24. THE CUSTOMER REPORTED TINY ARTEFACTS AND FREE FLOATING CELLS DURING THE WEAK D TESTING. AS THE CUSTOMER IS NEW TO THE IH-SYSTEM THEY ASKED FOR SOME INTERPRETATION GUIDANCE AND HOW THEY SHOULD HANDLE THESE KINDS OF RESULTS. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE LOT FOR INVESTIGATIONAL TESTING NOR SAMPLES THAT CAUSED QUESTIONABLE RESULTS. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT KNOWN DONOR SAMPLES USING THE IH-ANTI-D BLEND LOT #8932170-01 AS USED BY THE CUSTOMER. THE COMPLAINT TESTING WAS PERFORMED ON TWO DIFFERENT IH-READER 24 DEVICES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. THE DONOR SAMPLES SHOWED CLEARLY NEGATIVE RESULTS, EVALUATED BOTH VISUALLY AND BY THE SOFTWARE OF THE INSTRUMENT. WE DID NOT OBSERVE ANY ARTIFACTS OR FREE-FLOATING CELLS IN THE GEL COLUMN. RESULT IMAGES WERE PROVIDED THAT SHOWED PROCESSED CARDS OF THE SUPPOSEDLY DEFECTIVE LOT WHICH CONFIRMED THE CUSTOMER'S FINDINGS OF SPECKS IN THE GEL COLUMN. ONE SAMPLE WAS GRADED WITH A 1+ REACTION BY THE SOFTWARE AND IN REPETITION ONLY A FEW SPECKS WERE VISIBLE. HOWEVER, DUE TO MISSING INFORMATION LIKE ORIGINAL IHCARD IMAGES AND CALIBRATION FILES, IT WAS NOT POSSIBLE TO ANALYZE THE CASE IN DETAIL. THE CUSTOMER WAS ADVISED THAT THE IH-COM IS PROGRAMMED TO RULE OUT SMALL BUBBLES OR ARTIFACTS-FOR THE MOST PART, SO THESE TINY ANOMALIES SHOULD NOT IMPACT THE INTERPRETATIONSAS IT SEEMS THEY ARE NOT IN MOST CASES. THE IH-COM ALGORITHM TAKES INTO ACCOUNT SOME ARTIFACTS, BUBBLES, EVEN SOME MICRO-CLOTS THAT ARE NOT TRUE AGGLUTINATION. BASED ON THE IMAGE WITH A 1+ INTERPRETATION BY THE SOFTWARE PROVIDED BY CUSTOMER THE COMPLAINT IS CLASSIFIED AS CONFIRMED - UPP (UNEXPECTED PRODUCT PERFORMANCE). HOWEVER, THE RETENTION SAMPLE REACTED AS EXPECTED. AN INVESTIGATION OF THE EVALUATION ON THE IH-READER 24 WAS NOT POSSIBLE DUE TO THE ABSENCE OF REQUIRED INFORMATION AND FILES. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. AS A 1+ REACTION IN BLOOD GROUPING USING IH-ANTI-D BLEND IS NOT INTERPRETABLE BY THE SOFTWARE AND DOES REQUIRE AN OPERATOR INTERVENTION, NO INCORRECT RESULT WAS RELEASED. THE CUSTOMER WAS ADVISED BY A BIO-RAD IMMUNOHEMATOLOGY TECHNICAL SPECIALIST HOW TO HANDLE THESE KINDS OF IMAGES CORRECTLY.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TINY ARTEFACTS AND FREE FLOATING CELLS IN HER RESULTS WITH IH-CARD AHG ANTI-IGG. THE CUSTOMER STATED THAT SHE WAS VALIDATING THE WEAK D TESTING ON HER IH-READER 24. SHE REPORTED THAT THE INSTRUMENT CALLED THE AFFCTED REACTIONS EITHER AS QUESTION MARK OR AS NEGATIVE. SHE REVIEWED THE RESULTS AND FELT THEY SHOULD HAVE BEEN POSITIVE. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE SAMPLES THAT HAD CAUSED THE INCORRECT RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT AND THE RETENTION SAMPLE OF THE IH-ANTI-D BLEND LOT THE CUSTOMER HAD USED. TESTING WAS PERFORMED WITH DIFFERENT DONOR SAMPLES USING TWO DIFFERENT IH-READER 24. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NEITHER OBSERVE ANY TINY ARTEFACTS NOR FREE FLOATING CELLS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. WE ARE STILL WAITING FOR THE INSTRUMENT FILES FROM THE CUSTOMER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154404 ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG IH-CARD AHG ANTI-IGG (RABBIT); 48 CARD QHS BIO-RAD MEDICAL DIAGNOSTICS GMBH 8001010 07611969952168

    Patients

    Seq Age Sex Outcome Treatment
    1 IH-READER 24, SN (B)(6)| IH-READER 24, SN (B)(6)